6.0 Resource management 6.1 Provision of resources The manufacturing organization sha ...

4. Quality management system 4.1 General The manufacturer shall establish, document, ...

(e) all personnel shall bear clean body covering appropriate to their duties. Smoking ...

3.13 Quality audit means a systematic, independent examination of a manufacturer's qu ...

Planning of product realization The manufacturer shall plan and develop the processes ...

5.0 Management responsibility 5.1 Management commitment Top management of the manufac ...

These processes shall be managed by the manufacturer in accordance with the requireme ...

3.18.2 Design validation means establishing by objective evidence that device specifi ...